........... 27 Other Biographical Sketches (Not to exceed four pages for each- See instructions)) ........................ 31 Resources ................................................................................................................................................. 128 Research Plan Introduction to Revised Application (Not to exceed 3 pages) ......................................................................................................... Introduction to Supplemental Application (Not to exceed one page) .............................................................................................. 131 A. Specific Aims ........................................................................ _'t ..................................................................................... 131 B. Background and Significance ................................................ "'"'l" ................................................................................... |" C. Preliminary Studies/Progress Report/ _ (Items A-D: not to exceed 25 pages*) ,_ 132 Phase I Progress Report (SBIR/STTR Phase II ONLY) I * SBIR/STTR Phase I: Items A-D limited to 15 pages. I 1 1 D. Research Design and Methods ............................................. _ ..................................................................................... 142 E. Human Subjects ................................................................................................................................................................ 181 Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") t81 Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ................................................................ 182 Inclusion of Minorities (Required if Item 4 on the Face Page is marked '_es") .............................................................. 182 Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ................................................................ 144 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked '_es" anda Phase I, II, or II1clinical trial is proposed ...................................................................................................................................................... F. Vertebrate Animals ............................................................................................................................................................ 183 G. Literature Cited .................................................................................................................................................................. 183 H. Consortium/Contractual Arrangements .............................................................................................................................. 183 I. Letters of Support (e.g., Consultants) ................................................................................................................................. J. Product Development Plan (SBIPJSTTR Phase II and Fast-Track ONLY) ......................................................................... Checklist .................................................................................................................................................... 186 Appendix (Five collated sets. No page numbedng necessary for Appendix.) Check if Appendices NOT PERMITTED for Phase I SBIR/STTR unless specifically solicited. D AInpcpluednedix is Number of publica_ons and manuscripts accepted for publication (not to exceed 10) Other items (list): PHS 398 (Rev. 05/01) Page 4 Form Page 3